efficacy and safety of dt01 tablets in patients with irritable bowel syndrome with diarrhea

Conditions: Irritable Bowel Syndrome With Diarrhea

Summary: this is a phase ii, double-blind, randomized, 3-arm, placebo-controlled study to evaluate the efficacy and describe the safety of dt01 tablets in adults with ibs-d. patients who meet all entry criteria will be randomized to receive dt tablets or placebo or both for 8 weeks. the study drug will be taken three times daily. investigators will conduct phone-based assessments on days 7, 14, 21, 28, 35, 42, 49. patients will return to the clinic after dosing has completed (day 56) for a follow-up visit.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older. * has a diagnosis of ibs-d (irritable bowel syndrome with diarrhea) and meets the rome iv criteria * additional criterion: more than 3 bowel movements per day at least 25% of the time in the last 3 months. * for patients older than 50 years or patients with a positive family history of colorectal cancer: normal results from colonoscopy/flexible sigmoidoscopy performed within the last 2 years. * for patients aged 65 years or older: absence of ischaemic colitis, microscopy colitis or any other organic gastrointestinal disease as evidenced by the results of a colonoscopy/flexible sigmoidoscopy with biopsy performed within 12 months. * mentally competent, able to give written informed consent, and compliant to undergo all visits and procedures. * unrestricted access to a touch-tone telephone. * willingness to refrain from using loperamide within 3 days prior to run-in visit and during the run-in period. * for women of childbearing potential: use of a highly effective contraceptive method with a failure rate \<1% per year throughout the entire study period. additional criteria at randomisation: during both weeks of the run-in period: 1. a weekly average of worst abdominal pain in the past 24 hours with a score of ≥ 3.0 according to the visual analogue scale (vas). 2. at least one bowel movement on each day. 3. a weekly average of at least 3 bowel movements per day. 4. at least one stool with a consistency of type 6 or type 7 according to the bristol stool scale (bss) on at least 2 days per week. 5. less than 2 bowel movements with a consistency of type 1 or type 2 according to the bss per week. 6. adequate compliance with the diary recording procedure defined as at least ≥80% of the nominal daily data entry. exclusion criteria: * diagnosis of ibs with a subtype of constipation, mixed ibs, or un-subtyped ibs. * history of organic gi abnormalities, inflammatory bowel diseases, complicated diverticulosis, ischaemic colitis, microscopic colitis. * history of pancreatitis, active biliary duct disease, cholecystitis or symptomatic gallbladder stone disease in the previous 6 months. * history of gluten enteropathy or lactose intolerance. * hypersensitivity to the active substances or to any of the excipients of study drug or placebo. * history of major cardiovascular events in the previous 6 months. * history of human immunodeficiency virus infection. * uncontrolled hypertension, insulin-dependent diabetes mellitus or abnormal thyroid function. * evidence of clinically significant hepatic disease, severe renal insufficiency or anemia. * use of prohibited concurrent medication within the previous month such as antibiotics, antimuscarinic drugs, drugs enhancing gi motility and analgesics. * pregnancy or breastfeeding. * inability to understand or collaborate throughout the study. * participation in other clinical studies in the previous 4 weeks or concomitant enrollment in a clinical study. * any condition that would compromise the well-being of the patient.